Clinical Trial Sites Reflecting Their Communities

I posted earlier this year about the psychology of a good acquisition and the importance to buyers and sellers of finding “best fit” partners who share similar values, goals and cultures. Continuing this theme, I would like to flip the coin now to consider community fit as an additional predictor and driver for post-acquisition success.

In IMA’s clinical research business, the research site’s relationship with the community and the patients who volunteer to participate in our clinical trials is critically important. Without a steady stream of patient volunteers, the pace of research stalls and new treatments cannot be approved in time to help others with life-threatening needs.

The Impact of Patient and Doctor Alignment on Clinical Trial Recruitment

Among factors that can impact the recruitment of patients into clinical trials is the racial and ethnic alignment between patients and doctors. In a series of biennial international surveys conducted since 2013, The Center for Information and Study on Clinical Research Participation, Inc.’s (CISCRP) reported on the changing importance of diversity. In its most recent (2021) Public and Patient Perception & Insights study of 11,793 respondents, more than 75% reported that they were very willing (30%) or somewhat willing (47%) to participate in a clinical research study.

The importance of diversity in deciding to join a clinical study was assessed and most respondents (64%) indicated that knowing study staff and study participants are representative of diverse communities was important, highlighting the significance of diversity and inclusion within clinical research. Black respondents were more likely to report that having both diverse staff and diverse participants was ‘Very Important’ (44%) than White (25%) and Asian respondents (27%) This interest in having other diverse representatives involved in the research is not unexpected because black respondents were also more concerned than any other race about past events where participants were mistreated (47%).

This research suggests that clinical research sites who reflect the racial and ethnic composition of their communities, who also offer research studies that are relevant to the community and include representatives of diverse communities should do better at recruiting patients into clinical trials.

The Importance of Diversity in Clinical Trials

In 2016 (updated in April 2022), the FDA released draft guidance on the inclusion of diverse populations in clinical trials, emphasizing the importance of including individuals from underrepresented populations, such as racial and ethnic minorities, women, and the elderly. The guidance acknowledges that a lack of diversity in clinical trials can lead to underrepresentation of important subgroups, resulting in inadequate information on the safety and efficacy of the drug for those populations.

Ensuring that participants in clinical trials are representative of the broader population most likely to use the drug if the drug is approved can help ensure that new treatments are safe and effective for everyone. Moreover, clinical trials that include a diverse group of participants can help address health disparities that may exist within certain populations.

In a highly visible way, FDA put this guidance into action during the development of COVID-19 vaccines. There was an enrollment halt in some vaccine trials to balance diversity among participants. While this did delay completing the clinical trials, it ultimately resulted in more inclusive and effective vaccines that are approved worldwide.

Diversity Considerations for Clinical Trial Site Acquisition

We believe that alignment of clinical trial site staff and community ethnicity should be considered during acquisition due diligence because it can impact the success of clinical trials and the value of the acquisition. For example, if staff at a clinical trial site do not reflect the diversity of the community, this could lead to difficulties in recruiting patients, lower participation rates, and ultimately, a delay in the completion of the trials. This can increase the overall cost of the trial and negatively impact the acquisition value. Additionally, FDA initiatives to make studies more inclusive will drive pharmaceutical innovators to search out sites that can predictably deliver diverse populations into trials making sites with poor community alignment less likely to be awarded new studies.

IMA’s Clinical Research’s recent acquisitions illustrate how we have included diversity considerations while expanding geographic footprint and therapeutic capability. We are very pleased that Accelemed Research Institute, our most recent acquisition, offers strong ethnic, cultural and linguistic alignment with its community while providing research opportunities that are very relevant to the resident patient base. We are confident that this mix of attributes will promote continued success in recruiting patients into an even greater number of studies within the IMA site network which in turn will help more patients access advanced treatments.